ABSTRACT
Background: The aim of this study was to evaluate prevalence, causality, severity, classes of drugs involved in ADRs, organ system affected, underlying cause and management of Adverse drug reactions.
Subjects and methods: An observational prospective study was conducted over a 6 months period in Department of General Medicine using stimulated spontaneous reporting system for identifying ADRs. A questionnaire modified from previous studies and CDSCO-ADR reporting form was used as a data collection tool for this study keeping in mind.
Results: The present study was initiated in order to study prevalence, causality, severity, classes of drugs involved in ADRs, organ system affected, underlying cause and management. In this study, 181 patients were identified with ADRs. This includes (36) (19.8%) ADRs after Hospital admissions (Group-1) and 146 (80.1%), ADR causing hospital admissions (Group-2). The incidence of total ADRs was 5.6% (Group-1 (1.1%), Group-2 (4.53 %). Inter-individual variations were found to be the underlying cause for ADRs in the majority of the patients. Drug withdrawal followed by symptomatic treatment was found to be the most potent management. The occurrence of life-threatening reactions was found to be (8.9%), following three deaths due to adverse drug reactions.
Conclusions: The result showed that the ADRs in patients are a significant public health issue, impose a significant burden on patients through prolongation of hospital stay, increase in the admission rate, health care cost, morbidity, and mortality. Since there are considerable social and economic consequences of ADRs and the majority of these ADRs are predictable and often preventable, hence there is a need for greater awareness among the patients & health care professionals and also there is a need to improve the pharmacovigilance system in order to protect the Indian population from potential harm.
Keywords: Adverse Drug Reactions, Prevalence, Causality, Severity, Pharmacovigilance.